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1.
Exploring the opportunities for alignment of regulatory postauthorization requirements and data required for performance-based managed entry agreements.
Int J Technol Assess Health Care
; 37(1): e83, 2021 Aug 23.
Artículo
en Inglés
| MEDLINE | ID: mdl-34424152
2.
Regulatory and Evidence Requirements and the Changing Landscape in Regulation for Marketing Authorisation.
Recent Results Cancer Res
; 213: 169-187, 2019.
Artículo
en Inglés
| MEDLINE | ID: mdl-30543013
3.
Histology independent drug development - Is this the future for cancer drugs?
Cancer Treat Rev
; 123: 102674, 2024 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-38176220
4.
The European Medicines Agency review of pixantrone for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's B-cell lymphomas: summary of the scientific assessment of the committee for medicinal products for human use.
Oncologist
; 18(5): 625-33, 2013.
Artículo
en Inglés
| MEDLINE | ID: mdl-23615696
5.
The European Medicines Agency review of cabazitaxel (Jevtana®) for the treatment of hormone-refractory metastatic prostate cancer: summary of the scientific assessment of the committee for medicinal products for human use.
Oncologist
; 17(4): 543-9, 2012.
Artículo
en Inglés
| MEDLINE | ID: mdl-22477727
6.
Extension of Indication for Authorised Oncology Products in the European Union: A Joint Effort of Multiple Stakeholders.
Front Med (Lausanne)
; 8: 790782, 2021.
Artículo
en Inglés
| MEDLINE | ID: mdl-34957158
7.
European Medicines Agency extension of indication to include the combination immunotherapy cancer drug treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) for adults with intermediate/poor-risk advanced renal cell carcinoma.
ESMO Open
; 5(6): e000798, 2020 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-33188050
8.
The European medicines agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the committee for medicinal products for human use.
Clin Cancer Res
; 18(17): 4491-7, 2012 Sep 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-22829199
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